A Comparative Analysis of Two Types of Exercise on Outcomes Following Total Knee Arthroplasty

Osteoarthritis, Knee Clinical Trial

Official title:

A Comparative Analysis of High Velocity and Standard Low Velocity Exercise Training on Rehabilitation Outcomes Following Total Knee Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01545986
• Other study ID #: 09-04
• Status: Completed
• Phase: N/A
• First received: February 26, 2012
• Last updated: March 1, 2012
• Start date: September 2009
• Est. completion date: December 2011

Study information

• Verified date: March 2012
• Source: Helen Hayes Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to compare the effects of two exercise programs, using low velocity (LV) and high velocity (HV) contractions, on outcomes of individuals who have undergone total knee arthroplasty (TKA). The experimental hypothesis was that individuals performing HV exercise, compared to LV, would exhibit superior outcomes.

Description:

The most effective type of exercise has not been identified for individuals who undergo total knee arthroplasty (TKA). High velocity (HV) exercise when compared to low velocity (LV) exercise produces greater gains in power and certain functional activities in older adults. The use of HV exercise for patients who undergo TKA has not been investigated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years to 89 Years

Eligibility

Inclusion Criteria:

• Adults aged 60- 89 years of age.

• primary unilateral TKA 10-21 days prior to the outpatient PT evaluation

• received inpatient rehabilitation at Helen Hayes Hospital

Exclusion Criteria:

• Any other lower extremity joint or back pain (not inclusive of recent Total knee arthroplasty) rated greater than four out of ten with weight-bearing

• any other lower extremity joint replacement surgery

• diagnosis of osteoporosis with history of fractures, uncontrolled hypertension, unstable cardiac or pulmonary problems, neurological disease affecting motor control, uncontrolled diabetes

• chest pain or shortness of breath on stair-climbing

• requirement of human assistance to walk in addition to the ambulation device

• inability to follow instructions to perform testing and/or exercise,

• participants who stated that they would not be available to complete 12 exercise sessions

• individual adherence with performance of a home exercise program (HEP) less than five of seven days at the end of the treatment period

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis, Knee

Intervention

Behavioral:
• Exercise
Participants attended standardized exercise (ex) sessions twice a week for six weeks for 12 sessions. Group speed differed for concentric contractions, sit to stand ex, walking, curbs, and stairs. The low velocity ex group performed a concentric contraction in two seconds, and high velocity group in one second or less. End range concentric hold, eccentric contraction, repetition (rep) rest and set rest were the same. Open chain ex was performed at 50% of one Repetition Maximum (RM) x 10 reps x one set and then 80% of 1RM x 10 reps x two sets. Curb height and 1RM was assessed at the first, fifth and ninth sessions. Manual stretching, balance ex, sit to stand support, level of aerobic ex, gait training, and functional training were assessed and progressed at any session.

Locations

Country	Name	City	State
United States	Helen Hayes Hospital	West Haverstraw	New York

Sponsors (1)

Lead Sponsor	Collaborator
Helen Hayes Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Six Minute Walk Test (6MWT) at six weeks	The distance walked in six minutes is measured for the 6MWT. A 150 foot hallway is used for the test. Standardized instructions are read to the participant. The participant is asked to walk as fast as he/she feels comfortable and safe in order to walk far as he/she can during six minutes. Distance is recorded in feet and later is converted to meters.	6 weeks	No
Secondary	Gait Abnormality Rating Scale (GARS)	The GARS is a rating of gait quality. The participant is videotaped walking 10 meters from front, back, left, and right views. No type of walking aid is allowed. Standardized instructions are read to the participant including that he/she should walk at his/her usual speed. At a later time the videotape is viewed to rate gait on a four point (0-3) Likert type scale. Zero is gait without deviations and 48 is greatest amount of gait deviations.	6 weeks	No
Secondary	Change from Baseline in Visual Analogue Scale (VAS) Pain at six weeks	The VAS Pain is a 10 cm horizontal line with the words "severe moderate slight" spread out along the whole length. The end points are labeled "Pain as bad as it could be" and "No pain". A pencil is given to the participant to mark his/her answer. Standardized instructions are read to the participant. The test is scored by a number from 0 to 100 as measured in mm along the line with zero being no pain and 100 being pain as bad as it could get.	6 weeks	No
Secondary	Change from Baseline in Timed Up and Go Test (TUG) at six weeks	The TUG records the time in seconds needed to stand from sitting, walk 3 meters, return, and sit into the chair. A standard chair with armrests is used. Assistive devices are allowed but no physical assistance is given. Standardized instructions are read to the participant. A practice walk through is given. Due to the possibility of fatigue the faster of the two times is recorded.	6 weeks	No
Secondary	Gait Velocity	The participant walks while being videotaped. Standardized instructions are read to the participant when he/she is told that he/she should walk at his/her usual pace to the end of a 10 meter walkway. A side view is used. The videotape is viewed later for scoring. The acceleration and deceleration time is excluded by recording only the time taken to walk across the central 4 meters. This time and the 4 meter distance are used to calculate velocity in meters per second.	6 weeks	No
Secondary	Change from Baseline in Short Form-36 (SF-36) at six weeks	The Short Form-36 (SF-36) is a 36 item paper questionnaire which measures general health. Standarized instructions read to the participant prior to him/her filling it out. Scores range from 0-100, with 100 being highest level of physical and mental health.	6 weeks	No
Secondary	Change from Baseline in Stair Climb Test at six weeks	The time used to climb a flight of 12 steps and descend is recorded. Standardized instructions are read to the participant. Time is recorded in seconds. A practice walk through is given. Due to the possibility of fatigue the faster of the two times is recorded.	6 weeks	No